Practical Metadata and Standards for Clinical Research

Tag: eSource

Just a quick post, the first for quite a few months, on a new draft FDA guidance. Back in late December 2010, the FDA released the first draft of an electronic source data guidance and now we have an updated document. The first point to note is that the guidance is still draft and this… Continue reading…

A few days ago I was alerted to a discussion thread on LinkedIn by a good friend. I started reading and became increasingly alarmed by what I found. The thread can be found here. Please read the thread. My concern is based around a commercial organization taking out a patent on work that I consider… Continue reading…

Over the last few months, Dave and I have been working hard and as a consequence our blogging has not been as prolific as it has been in past months. However, like all good ‘bloggers’ we continue to read the blogs of others with fervour. So I have been intrigued by a few posts in… Continue reading…